Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

H1N1 Vaccine

Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.

Shows the number of participants who had at least one adverse event (AE) in each category. These include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.

Time Frame

Measured up to 6 months after delivery

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All 128 pregnant women who received at least one vaccination are included in this analysis.

Reporting Groups

Description

H1N1 Vaccine

Pregnant women enrolled in the study.

Measured Values

H1N1 Vaccine

Number of Participants Analyzed
[units: participants]

128

The Number of Participants Who Had at Least One Adverse Event (AE)
[units: Participants]

Overall (New AEs after start of treatment)

118

Grade 4 AEs (New, after start of treatment)

11

Grade 3 AEs (New, after start of treatment)

8

Grade >=2 local and systemic AEs to injection

0

No statistical analysis provided for The Number of Participants Who Had at Least One Adverse Event (AE)

2. Primary:

The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine [ Time Frame: Measured up to 6 months after delivery ]

Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values [ Time Frame: Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose ]